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Congestion Relief by Meijer Distribution Inc

Medically reviewed on September 25, 2017

Dosage form: tablet, film coated
Ingredients: IBUPROFEN 200mg, PHENYLEPHRINE HYDROCHLORIDE 10mg
Labeler: Meijer Distribution Inc
NDC Code: 41250-158

Meijer Distribution, Inc. Congestion Relief Drug Facts

Active ingredients (in each tablet)

Ibuprofen 200 mg (NSAID)*

Phenylephrine HCl 10 mg

*nonsteroidal anti-inflammatory drug

Purposes

Pain reliever/fever reducer

Nasal decongestant

Uses
temporarily relieves these symptoms associated with the common cold or flu:
headache
fever
sinus pressure
nasal congestion
minor body aches and pains
reduces swelling of the nasal passages
temporarily restores freer breathing through the nose

Warnings

Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin.

Symptoms may include:

hives
facial swelling
asthma (wheezing)
shock
skin reddening
rash
blisters

If an allergic reaction occurs, stop use and seek medical help right away.

Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:

are age 60 or older
have had stomach ulcers or bleeding problems
take a blood thinning (anticoagulant) or steroid drug
take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
have 3 or more alcoholic drinks every day while using this product
take more or for a longer time than directed

Do not use
in children under 12 years of age because this product contains too much medication for children under this age
if you have ever had an allergic reaction to any other pain reliever/fever reducer
right before or after heart surgery
if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product

Ask a doctor before use if
stomach bleeding warning applies to you
you have problems or serious side effects from taking pain relievers or fever reducers
you have a history of stomach problems, such as heartburn
you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, thyroid disease, diabetes or have trouble urinating due to an enlarged prostate gland
you are taking a diuretic

Ask a doctor or pharmacist before use if you are
under a doctor’s care for any serious condition
taking any other product that contains phenylephrine or any other nasal decongestant
taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
taking any other drug

When using this product
take with food or milk if stomach upset occurs
the risk of heart attack or stroke may increase if you use more than directed or for longer than directed

Stop use and ask a doctor if
you experience any of the following signs of stomach bleeding:
feel faint
vomit blood
have bloody or black stools
have stomach pain that does not get better
pain gets worse or lasts more than 7 days
fever gets worse or lasts more than 3 days
nasal congestion lasts for more than 7 days
symptoms continue or get worse
redness or swelling is present in the painful area
you get nervous, dizzy, or sleepless
any new symptoms appear

If pregnant or breast-feeding,

ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions
do not take more than directed
adults and children 12 years of age and over:
take 1 tablet every 4 hours while symptoms persist.
do not use more than 6 tablets in any 24-hour period unless directed by a doctor
children under 12 years of age: do not use because this product contains too much medication for children under this age

Other information
store at 20-25°C (68-77°). Avoid excessive heat above 40°C (104°F).
read all warnings and directions before use. Keep carton.

Inactive Ingredients

acesulfame potassium, colloidal silicon dioxide, croscarmellose sodium, FD&C blue #2 aluminum lake, FD&C yellow #6 aluminum lake, iron oxide yellow, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, stearic acid, sucralose, talc, titanium dioxide

Questions?

1-800-719-9260

Principal Display Panel

Compare to Advil® Congestion Relief active ingredients

Non-Drowsy

Congestion Relief

Ibuprofen 200 mg / Phenylephrine Hydrochloride 10 mg Tablets

Pain Reliever / Fever Reducer (NSAID) & Nasal Decongestant

CONTAINS: Ibuprofen & Phenylephrine

NON-DROWSY relief of: Sinus Pressure, Nasal Swelling & Congestion, and Headache

20 Coated Tablets

Actual Size

1 Pill Dosage

CONGESTION RELIEF 
ibuprofen, phenylephrine hcl tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41250-158
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (IBUPROFEN) IBUPROFEN200 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
ACESULFAME POTASSIUM 
SILICON DIOXIDE 
CROSCARMELLOSE SODIUM 
FERRIC OXIDE YELLOW 
LACTOSE MONOHYDRATE 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOLS 
POLYVINYL ALCOHOL 
STEARIC ACID 
SUCRALOSE 
TALC 
TITANIUM DIOXIDE 
Product Characteristics
ColorBROWN (brownish-orange) Scoreno score
ShapeOVALSize15mm
FlavorImprint CodeL158
Contains    
Packaging
#Item CodePackage Description
1NDC:41250-158-6020 BLISTER PACK in 1 CARTON
11 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20320009/17/2014
Labeler - Meijer Distribution Inc (006959555)

 
Meijer Distribution Inc

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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